UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027398 |
|---|---|
| Receipt number | R000031399 |
| Scientific Title | The beneficial effect of a functional food containing Lactobacillus on human gastrointestinal function : double blind, placebo-controlled study |
| Date of disclosure of the study information | 2017/12/28 |
| Last modified on | 2017/12/28 13:16:04 |
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Basic information
Public title
The beneficial effect of a functional food containing Lactobacillus on human gastrointestinal function : double blind, placebo-controlled study
Acronym
The beneficial effect of a functional food containing Lactobacillus on human gastrointestinal function
Scientific Title
The beneficial effect of a functional food containing Lactobacillus on human gastrointestinal function : double blind, placebo-controlled study
Scientific Title:Acronym
The beneficial effect of a functional food containing Lactobacillus on human gastrointestinal function
Region
| Japan |
Condition
Condition
Individuals with a tendency for constipation
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to investigate the efficacy of the intake of the functional food on individuals with constipation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
defecation frequency, stool output
Key secondary outcomes
defecation days, fecal condition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
intake of a test food containing with lactobacillus for 2 consecutive weeks
Interventions/Control_2
intake of a placebo for 2 consecutive weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Males and females from 20 to 64 years of age
(2) Subjects with a tendency for constipation at three to five times of defecation per week
Key exclusion criteria
(1) Subjects who routinely takes foods or medicines containing of Lactobacillus
(2) Subjects who routinely takes foods or medicines containing of Bacillus subtilis var. natto
(3) Subjects who routinely takes foods or medicines affecting the test result
(4) Subjects having diseases affecting bowel movement or a history of these diseases
(5) Subjects having possibilities for emerging allergy related to the study
(6) Subjects who has asthma or the possibility of asthma
(7) Subjects who is employed on a pre-dawn shift or on night duty more than 2 times
(8) Subjects who is planned to go overseas
(9) Subjects who has treatment or a history of serious disease
(10) Subjects who has treatment of disease
(11) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on screening test
(12) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(13) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(14) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(15) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehisa Kumagai |
Organization
KAMEDA SEIKA CO., LTD.
Division name
RICE RESEARCH INSTITUTE
Zip code
Address
3-1-1 Kameda Kogyo Danchi, Konan-ku, Niigata City, Niigata
TEL
025-382-8879
t_kumagai@sk.kameda.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Yamamichi |
Organization
TTC Co.,Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
s.yamamichi@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
KAMEDA SEIKA CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 19 | Day |
Last modified on
| 2017 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031399
